[Federal Register Volume 65, Number 4 (Thursday, January 6, 2000)]
[Notices]
[Pages 783-784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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     This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 27, 2000, 8 a.m. 
to 6:30 p.m., and on January 28, 2000, 8 a.m. to 3 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Nancy T. Cherry or Denise H. Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville, MD 20852, 301-827-0314, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12391. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On January 27, 2000, the committee will: (1) Review the 
current understanding of the immune correlates of protection against 
invasive Haemophilus influenzae type b disease, and (2) discuss the 
potential clinical significance of reduced antibody responses to PRP 
(polyribitol phosphate) polysaccharide following administration of 
combination vaccines containing Haemophilus influenzae type b conjugate 
vaccines. On January 28, 2000, the committee will: (1) Discuss the 
influenza virus vaccine formulation for the 2000 to 2001 season, and 
(2) be briefed on selected individual research programs in the 
Laboratory of Pediatric and Respiratory Viral Diseases.
    Procedure: On January 27, 2000, from 9 a.m. to 6:30 p.m., and on 
January 28, 2000, from 8 a.m. to 2:25 p.m., the meeting is open to the 
public. Interested persons may present data, information, or views, 
orally or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person by January 19, 2000. Oral 
presentations from the public will be scheduled between approximately 
9:10 a.m. and 9:25 a.m. and between approximately 4 p.m. and 4:15 p.m. 
on January 27, 2000. Oral presentations from the public will be heard 
on January 28, 2000, between approximately 8:20 a.m. and 8:30 a.m., 
between approximately 1:30 p.m. and 1:40 p.m., and between 
approximately 2:15 p.m. and 2:25 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 19, 2000, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Closed Committee Deliberations: On January 27, 2000, from 8 a.m. to 
9 a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion of 
pending investigational new drug applications or pending product 
licensing applications. On January 28, 2000, from 2:25 p.m. to 3 p.m., 
the meeting will be closed to permit discussion where disclosure would 
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 
552b(c)(6)). The meeting will be closed to discuss personal information 
concerning individuals associated with the research programs.

[[Page 784]]

     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 23, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-237 Filed 1-5-00; 8:45 am]
BILLING CODE 4160-01-F